Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06370169
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-12-21
Brief Title:
EUS Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
Sponsor:
Asian Institute of Gastroenterology India
Organization:
Asian Institute of Gastroenterology India
Study Overview
Official Title:
Endoscopic Ultrasound Guided Coil Embolization for Primary Prophylaxis of Gastric Varices
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EUS
Brief Summary:
The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist
Detailed Description:
In this study Principal investigator recruiting patients with high-risk gastric varices for primary prophylaxis Gastric varices are dilated submucosal veins in the lining of the stomach found in patients with portal hypertension or elevated pressure in the portal venous system The standard treatment of bleeding gastric varices is obliteration with placement of coil and glue Our study will evaluate the efficacy of EUS guided coil as primary prophylaxis for high-risk gastric varices All procedures will be performed with patient under deep sedation or general anaesthesia under the supervision of an anaesthesiologist After the procedure patients will be discharged to home unless there is any indication for admission such as significant abdominal pain bleeding or chest pain For enrolment into the study patient has to sign an informed consent form which is provided at the end First we will do baseline evaluation of the patient which includes detailed clinical examination routine laboratory tests Upper GI Endoscopy triphasic CT abdomen The duration of study is 6 months Only the routine tests necessary for the management of disease will be charged
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None